VENKO GLOBAL LTD
⚠️ Moderate Risk
FEI: 3018518368 • Guangzhou, Guangdong • CHINA
FEI Number
3018518368
Location
Guangzhou, Guangdong
Country
CHINAAddress
121 Guangyuan West Rd, , Guangzhou, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VENKO GLOBAL LTD's FDA import refusal history?
VENKO GLOBAL LTD (FEI: 3018518368) has 10 FDA import refusal record(s) in our database, spanning from 4/21/2022 to 4/21/2022.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. VENKO GLOBAL LTD's FEI number is 3018518368.
What types of violations has VENKO GLOBAL LTD received?
VENKO GLOBAL LTD has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about VENKO GLOBAL LTD come from?
All FDA import refusal data for VENKO GLOBAL LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.